A Randomized Prospective Trial of 2-Octyl Cyanoacrylate (Derma-Bond) Tissue Adhesive Versus Running Subcuticular Suture Combined With Tissue Adhesive Versus Epidermal Sutures in Dermatologic Surgery Procedures of the Head and Neck
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Wound Healing
研究概览
简要总结
The goal of this study is to assess whether wound closure with skin adhesive or running stitches combined with skin adhesive will be superior to standard wound sutures. This is a split-wound study that will compare two methods of skin closure within one standard closure technique, thereby providing an internal control of running stitches within each wound. The investigators plan to measure outcomes by assessing for scar appearance, the incidence of wound opening, scar elasticity and subject satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 and over
- •Linear closures on the head and neck, at least 3cm in length
- •The subjects are in good health
- •The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.
排除标准
- •Under 18 years of age
- •Pregnancy or Lactation
- •Subjects who are unable to understand the protocol or to give informed consent
- •Subjects with mental illness
- •Defects on the scalp
研究组 & 干预措施
Running polypropylene closure
Half of every linear wound will be closed with running polypropylene sutures. This technique is Standard of Care.
干预措施: Running polypropylene closure (Procedure)
Tissue Adhesive (Derma-Bond)
The experimental half of the wound will be randomized to receive closure with tissue adhesive alone.
干预措施: Tissue Adhesive (Derma-Bond) (Procedure)
Subcuticular polyglactin-910 combined with tissue adhesive
The experimental half of the wound will be randomized to receive closure with running subcuticular polyglactin-910 combined with tissue adhesive.
干预措施: Subcuticular polyglactin-910 combined with tissue adhesive (Procedure)
结局指标
主要结局
Wound Healing
时间窗: 10 day/3 weeks and 3 months
The primary outcome measure of this study will be wound healing. This outcome will be assessed by the blinded observers, subject ratings and Cutometer measurements of scar elasticity. Two double-blinded dermatologists will be asked to rate the scars according to the objective scar scales at the 10 day/ 3 week and 3 month follow-up exams.
次要结局
- Dehiscence(10 days/3 weeks and 3 months)
- Adverse Events(10 days/3 weeks and 3 months)
- Subject Satisfaction(10 days/3 weeks and 3 months)
研究者
Murad Alam
Associate Professor of Dermatology
Northwestern University